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初始按需使用布罗珠单抗治疗渗出性年龄相关性黄斑变性:PROBE研究。

Initial Pro Re Nata Brolucizumab for Exudative AMD: The PROBE Study.

作者信息

Bilgic Alper, Kodjikian Laurent, Srivastava Samaresh, Dwivedi Shyamal, Banker Alay S, Abukashabah Amro, Sudhalkar Aditya, Mathis Thibaud

机构信息

Alphavision Augenarztpraxis Clinic, 27568 Bremerhaven, Germany.

Service d'Ophtalmologie, Centre Hospitalier Universitaire de la Croix-Rousse, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, 69004 Lyon, France.

出版信息

J Clin Med. 2021 Sep 15;10(18):4153. doi: 10.3390/jcm10184153.

Abstract

The present study aimed to determine the efficacy and safety of pro re nata (PRN) intravitreal brolucizumab therapy for neovascular age-related macular degeneration (AMD) without a loading dose in the real-world setting. The PROBE study (Pro Re Nata Brolucizumab for Exudative AMD) is a retrospective, observational, multicentric study that included 27 treatment-naïve patients (27 eyes) with neovascular AMD who received PRN brolucizumab therapy with the treatment interval being at least 8 weeks, should the need for a second consecutive injection arise. The primary outcome measure was changed to best-corrected visual acuity (BCVA) over time. Secondary outcome measures included the determination of change in central subfield thickness (CST) and complications. The mean follow-up was 11.2 ± 1.2 months. The mean baseline and final BCVA were 57.4 ± 4.5 letters and 65.3 ± 3.12 letters, respectively ( = 0.014). The mean gain in letters at the end of follow-up was 7.8 ± 3.5 letters. There was a significant decrease in CST at the end of the follow-up period ( = 0.013). Patients received a mean of 2.2 ± 0.9 injections (in addition to the first mandatory injection) during the follow-up period. There were no adverse events noted. In conclusion, initial PRN brolucizumab for exudative AMD without a loading dose demonstrated significant visual improvement and no adverse events.

摘要

本研究旨在确定在现实环境中按需玻璃体内注射布罗珠单抗治疗新生血管性年龄相关性黄斑变性(AMD)且不给予负荷剂量时的疗效和安全性。PROBE研究(按需布罗珠单抗治疗渗出性AMD)是一项回顾性、观察性、多中心研究,纳入了27例初治的新生血管性AMD患者(27只眼),这些患者接受了按需布罗珠单抗治疗,若需要连续第二次注射,治疗间隔至少为8周。主要结局指标改为随时间变化的最佳矫正视力(BCVA)。次要结局指标包括确定中心子野厚度(CST)的变化和并发症。平均随访时间为11.2±1.2个月。平均基线BCVA和最终BCVA分别为57.4±4.5个字母和65.3±3.12个字母(P = 0.014)。随访结束时字母数的平均增加为7.8±3.5个字母。随访期末CST有显著下降(P = 0.013)。随访期间患者平均接受2.2±0.9次注射(除首次强制注射外)。未观察到不良事件。总之,初始按需使用布罗珠单抗治疗渗出性AMD且不给予负荷剂量可显著改善视力且无不良事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f86/8465009/cc12a1e58774/jcm-10-04153-g001.jpg

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